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BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation Devices are sterile, single-use bipolar electrosurgical devices intended to deliver RF energy and saline for coagulation of soft tissue and bone at the operative site. It is intended for but not limited to orthopedic, spine, endoscopic procedures, abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation devices are sterile. single-use bipolar electrosurgical devices intended to deliver RF energy and saline for coagulation of soft tissue and bone at the operative site. It is intended for but not limited to orthopaedic, spine, endoscopic procedures, abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization.)

DEVICE COMPONENTS AND OPERATION:

• 1. Insulated Handle:
     The Insulated Handle encases the shaft and tip and one of the controlling mechanisms for the flow of saline. The activation of RF current is accomplished by footswitch.

There are two flow control mechanisms so the flow of saline (one directly on the handle and a roller clamp just proximal to the handle). Saline flow can be regulated by the user within the sterile field. The saline delivery tubing is approximately ten (10) feet in length and incorporates an I.V. spike on the end to attach directly to a hanging IV (saline) bag.

The Handle power cord is approximately ten (10) feet in length and incorporates a 3-prong electrical plug.

The insulation on the Handle and Power Cord meets the requirements for Dielectric Withstands of Accessories.

• 2. Shaft and Electrode Tip:
     The electrode tip delivers RF energy for coagulation and delivers saline which is gravity-fed from an intravenous bag to the tip. There are three handle shape configurations: straight shaft, angled shaft, and laparoscopic shaft. Each is constructed of the same materials.

These devices use technology substantially equivalent to the Aquamantys SS4.0 Bipolar Sealer (K-063639) and the Aquamantys 6.0 Bipolar Sealer (K-052859). Both consist of an electrode tip that is used to coagulate tissue through the utilization of high frequency radiofrequency energy and saline.

BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation devices are provided sterile, sterilized using ethylene oxide gas, and are for single use only.

These devices conform to the requirements of safety standard IEC 60601-2-2. There are no significant differences in technology, performance, or intended use between BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation devices and predicate devices. There are no new questions raised regarding safety or effectiveness.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation Device, structured according to your request.

Please note: The provided document is a 510(k) summary for a medical device seeking substantial equivalence. It focuses on demonstrating that the device is as safe and effective as a legally marketed predicate device, rather than providing detailed acceptance criteria and a comprehensive study report with clinical performance metrics as one might find for a novel device or a clinical trial. Therefore, some of the requested information (especially regarding clinical performance, expert involvement for ground truth, and human-in-the-loop studies) is not present in this type of regulatory submission and cannot be extracted.

Acceptance Criteria and Device Performance Study for BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation Device

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria for clinical performance. The "acceptance criteria" here are implicitly related to meeting the fundamental safety and effectiveness requirements by being similar to already approved devices. The "study" refers to the comparison made against the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a clinical "test set" with a specific sample size in the way one would for a clinical trial assessing performance. The evaluation is based on a comparison to predicate devices, focusing on technological equivalency, intended use, and safety standards. Therefore, there is no discrete sample size used for a test set or information on data provenance (e.g., country of origin, retrospective/prospective) in the context of clinical performance data in this 510(k) summary. The "test" is largely a comparison of specifications and design to the predicates, combined with compliance to safety standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided as the submission is a 510(k) for substantial equivalence and does not detail a study where expert-established ground truth for a test set would be required for performance evaluation in the clinical sense.

4. Adjudication Method for the Test Set

This information is not provided as there is no described clinical "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable/not provided. The device is an electrosurgical tool, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to human cognitive performance or AI assistance would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable/not provided. The device is a surgical instrument and does not involve standalone algorithm performance in the context of AI or diagnostic imaging.

7. The Type of Ground Truth Used

The 'ground truth' in this 510(k) context is implicitly the established safety and effectiveness of the predicate devices (TissueLink: Aquamantys 2.3 Bipolar Sealer and 6.0 Bipolar Sealer, and Aquamantys SS4.0 Bipolar Sealer). The submission aims to demonstrate that the new device operates similarly and meets the same safety profiles as these already approved devices. Therefore, the "type of ground truth" is regulatory approval and established performance of predicate devices.

8. The Sample Size for the Training Set

This information is not applicable/not provided. As explained, the device is an electrosurgical tool, not an AI or machine learning model that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the reasons stated in point 8.

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